Regulatory

SubCheck

Cleaner submissions before handoff.

What it does

SubCheck performs structured checks across submission packages to surface missing or inconsistent elements before final handoff. It is designed as a quality gate rather than a replacement for submission platforms.

Problem solved

Submission packages can accumulate preventable omissions and inconsistencies that are discovered too late in the handoff process.

Best suited for

Regulatory and submission teams that want a structured pre-handoff quality gate.

Typical use

Used during closeout or submission preparation to identify gaps before package handoff.

Deployment

Hosted Saas

Implementation

A practical view of what it may take to use this product in your environment.

Implementation requirements

API or structured data transfer may be required
Security review likely
Validation/UAT required
IT or platform administration involvement

Technical considerations

Structured file ingestion
Optional API connectivity
Audit logging supported
Validation plan recommended

Compliance & validation

Product information below is creator-supplied unless ClinExchange explicitly states otherwise.

21 CFR Part 11

ClinExchange review pending

Part 11-related capabilities have been identified for review, but an independent marketplace review has not yet been completed.

A marketplace listing is not a regulatory certification. Sponsors remain responsible for assessing fitness for intended use, validation, and applicable regulatory requirements.

Validation & review information

Validation available: Yes
Security review available: Yes
Privacy: Formal security, privacy, and validation assessment is recommended before production use.

Evidence

Audit trail documentation

Available

Validation documentation

Available

Security questionnaire

Available

Creator

Maya Brooks

Regulatory Lead · Independent

Regulatory technology professional focused on submission readiness and practical quality controls.

Contact Creator